This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. The trial will include up to a 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 75 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04781543 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Horizon Therapeutics Ireland DAC |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Medical Director |
Principal Investigator Affiliation | Horizon Therapeutics |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Austria, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Romania, Spain, Switzerland, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic |
Experimental: HZN-825 300 mg once daily (QD)
One set of 2 HZN-825 150mg tablets in the morning and one set of 2 placebo tablets in the evening.
Experimental: HZN-825 300 mg twice daily (BID)
One set of 2 HZN-825 150mg tablets in the morning and one set of 2 HZN-825 150mg tablets in the evening.
Placebo Comparator: Placebo
One set of 2 placebo tablets in the morning and one set of 2 placebo tablets in the evening.
Drug: - HZN-825 BID
300 mg oral tablets BID
Drug: - Placebo
Placebo BID
Drug: - HZN-825 QD
300 mg oral tablets QD
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85032
Status
Recruiting
Address
Pacific Arthritis Care Center
Los Angeles, California, 90045
Status
Recruiting
Address
UCLA Department of Medicine
Los Angeles, California, 90095-1670
Status
Recruiting
Address
Stanford University School of Medicine
Palo Alto, California, 94304
Status
Recruiting
Address
University of Miami Miller School of Medicine
Miami, Florida, 33136
Status
Recruiting
Address
IRIS Research and Development LLC
Plantation, Florida, 33324
Status
Recruiting
Address
DelRicht Clinical Research, LLC
New Orleans, Louisiana, 70115
Status
Recruiting
Address
Boston University School Of Medicine
Boston, Massachusetts, 02118-2642
Status
Recruiting
Address
Michigan Medicine University of Michigan
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Mayo Clinic - Cancer Center - Rochester - PPDS
Rochester, Minnesota, 55905
Status
Recruiting
Address
Hospital For Special Surgery
New York, New York, 10021-4823
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27713
Status
Recruiting
Address
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425-8900
Status
Recruiting
Address
Metroplex Clinical Research Center
Dallas, Texas, 75231
Status
Recruiting
Address
UT Physicians Rheumatology
Houston, Texas, 77030
Status
Recruiting
Address
Framingham Centro Médico
La Plata, Buenos Aires, B1902COS
Status
Withdrawn
Address
Consultorios Médicos Dr. Catalán Pellet
Recoleta, Ciudad Autónoma De BuenosAires, C1111AAL
Status
Recruiting
Address
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucuman, Tucumán, T4000AXL
Status
Recruiting
Address
Consultorio de Investigaciones Reumatologicas
San Miguel De Tucumán, Tucumán, T4000AXL
Status
Recruiting
Address
Clinica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán, T4000
Status
Recruiting
Address
Organización Médica de Investigación
Ciudad Autónoma de Buenos Aires, , C1015
Status
Recruiting
Address
Aprillus Asistencia e Investigacion de Arcis Salud SRL
Ciudad Autónoma de Buenos Aires, , C1406AGA
Status
Recruiting
Address
Consultorio Médico Dra. Rivera
Ciudad Autónoma de Buenos Aires, , C1426
Status
Recruiting
Address
Clínica Adventista Belgrano
Ciudad Autónoma de Buenos Aires, , C1430
Status
Recruiting
Address
I.R. Medical Center - Hospital de Dia
Mendoza, , M5500CPH
Status
Recruiting
Address
Medizinische Universität Graz
Graz, Steiermark, 8010
Status
Recruiting
Address
Medizinische Universitat Wien (Medical University of Vienna)
Wien, , 1090
Status
Recruiting
Address
Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas-Rhin, 67000
Status
Recruiting
Address
Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
Bordeaux, Gironde, 33000
Status
Recruiting
Address
Hôpital de Rangueil
Toulouse, Haute-Garonne, 31000
Status
Recruiting
Address
Hôpital Claude Huriez
Lille, Nord, 59000
Status
Recruiting
Address
Hopital Cochin
Paris, , 75014
Status
Recruiting
Address
Friedrich Alexander Universität Erlangen Nürnberg
Erlangen, Bayern, 91054
Status
Not yet recruiting
Address
LMU Klinikum der Universität
München, Bayern, 80336
Status
Recruiting
Address
Universitätsklinikum Würzburg
Würzburg, Bayern, 97080
Status
Recruiting
Address
Universität Georg August
Göttingen, Niedersachsen, 37075
Status
Recruiting
Address
Universitatsklinikum Dusseldorf
Düsseldorf, Nordrhein-Westfalen, 40225
Status
Recruiting
Address
Universitatsklinikum Halle (Saale)
Halle, Sachsen-Anhalt, 6120
Status
Recruiting
Address
Charité - Universitätsmedizin Berlin
Berlin, , 10117
Status
Recruiting
Address
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , 1307
Status
Recruiting
Address
Laiko General Hospital of Athens
Athens, Attiki, 115 27
Status
Recruiting
Address
Laiko General Hospital of Athens
Athina, Attiki, 115 27
Status
Recruiting
Address
Kianous Stavros
Thessaloniki, , 546 36
Status
Recruiting
Address
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , 564 29
Status
Recruiting
Address
Meir Medical Center
Kfar Sava, HaMerkaz, 44281
Status
Recruiting
Address
Tel Aviv Sourasky Medical Center
Tel Aviv-Yafo, Tel-Aviv, 64239
Status
Recruiting
Address
Rambam Medical Center - PDDS
Haifa, , 31096
Status
Recruiting
Address
Lady Davis Carmel Medical Center
Haifa, , 34362
Status
Recruiting
Address
Rabin Medical Center
Petah tikva, , 49100
Status
Recruiting
Address
Sheba Medical Center
Tel HaShomer, , 52621
Status
Not yet recruiting
Address
Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
Udine, Friuli-Venezia Giulia, 33100
Status
Recruiting
Address
Fondazione Policlinico Universitario A Gemelli
Roma, Lazio, 00168
Status
Recruiting
Address
Ospedale Policlinico San Martino
Genova, Liguria, 16132
Status
Recruiting
Address
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardia, 27100
Status
Recruiting
Address
Istituto Clinico Humanitas
Rozzano, Lombardia, 20089
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Careggi
Firenze, Toscana, 50141
Status
Recruiting
Address
Azienda Ospedaliero Universitaria Pisana
Pisa, , 56126
Status
Recruiting
Address
Fujita Health University Hospital
Toyoake-shi, Aiti, 470-1192
Status
Recruiting
Address
Sapporo Medical University Hospital
Sapporo-Shi, Hokkaidô, 060-0061
Status
Recruiting
Address
Hokkaido University Hospital
Sapporo-Shi, Hokkaidô, 060-8648
Status
Recruiting
Address
Kumamoto University Hospital
Kumamoto-Shi, Kumamoto, 860-0811
Status
Recruiting
Address
Tohoku University Hospital
Sendai-shi, Miyagi, 980-8574
Status
Recruiting
Address
Nagasaki University Hospital
Nagasaki-Shi, Nagasaki, 852-8501
Status
Recruiting
Address
Saitama Medical University Hospital
Iruma-Gun, Saitama, 350-0495
Status
Recruiting
Address
Kitasato University Medical Center
Kitamoto-Shi, Saitama, 364-0026
Status
Recruiting
Address
Juntendo University Hospital
Bunkyo-Ku, Tokyo, 113-8431
Status
Not yet recruiting
Address
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
Status
Recruiting
Address
Kyushu University Hospital
Fukuoka, , 812-8582
Status
Recruiting
Address
St. Luke's International Hospital
Tokyo, , 104-8560
Status
Recruiting
Address
Nippon Medical School Hospital
Tokyo, , 113-8603
Status
Recruiting
Address
Osaka University Hospital
Suita-Shi, Ôsaka, 565-0871
Status
Recruiting
Address
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-Shi, Ôsaka, 569-8686
Status
Recruiting
Address
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, 13620
Status
Recruiting
Address
Hanyang University Seoul Hospital
Seongdong-gu, Seoul Teugbyeolsi, 4763
Status
Recruiting
Address
Chonnam National University Hospital
Gwangju, , 61469
Status
Recruiting
Address
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , 6273
Status
Recruiting
Address
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Ciudad de México, Distrito Federal, 14080
Status
Recruiting
Address
CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV
Mexico, Distrito Federal, 6700
Status
Recruiting
Address
Centro de Investigación y Tratamiento Reumatológico S.C
Miguel Hidalgo, Distrito Federal, 11850
Status
Recruiting
Address
Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara, Jalisco, 44690
Status
Recruiting
Address
Centro Integral Reumatologia SA de CV
Guadalajara, Jalisco, ZC 44160
Status
Recruiting
Address
Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
Burócratas del Estado, San Luis Potosí, 78213
Status
Recruiting
Address
Unidad de Atencion Medica e Investigacion en Salud
Merida, Yucatán, 97000
Status
Recruiting
Address
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, , 44650
Status
Withdrawn
Address
Leids Universitair Medisch Centrum
Leiden, Zuid-Holland, 2333 ZA
Status
Recruiting
Address
Universitair Medisch Centrum Groningen
Groningen, , 9713 GZ
Status
Recruiting
Address
Twoja Przychodnia NCM
Nowa Sól, Lubuskie, 67-100
Status
Recruiting
Address
Medicover Integrated Clinical Services sp. z o.o
Warszawa, Mazowieckie, 00-874
Status
Recruiting
Address
Centrum Medyczne Reuma Park NZOZ
Warszawa, Mazowieckie, 02-665
Status
Recruiting
Address
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi
Poznan, Wielkopolskie, 61-545
Status
Recruiting
Address
MCM Krakow - PRATIA
Kraków, , 30-510
Status
Recruiting
Address
Hospital Garcia de Orta
Almada, Setúbal, 2805-267
Status
Recruiting
Address
Hospital de Braga
Braga, , 4710-243
Status
Recruiting
Address
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, , 3000-459
Status
Recruiting
Address
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisboa, , 1649-035
Status
Recruiting
Address
Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho
Ponte De Lima, , 4990-041
Status
Recruiting
Address
Centro Hospitalar de São João, E.P.E.
Porto, , 4200-319
Status
Withdrawn
Address
Sf.Maria Clinical Hospital
Bucharest, Bucuresti, 11172
Status
Recruiting
Address
Sf.Maria Clinical Hospital
Bucharest, Bucuresti, 11172
Status
Recruiting
Address
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
Brasov, , 500283
Status
Not yet recruiting
Address
Dr I Cantacuzino Clinical Hospital
Bucuresti, , 20475
Status
Recruiting
Address
Hospital de Merida-Avenida d' Antonio Campos Hoyos 26
Merida, Badajoz, 6800
Status
Recruiting
Address
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 8208
Status
Recruiting
Address
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Status
Recruiting
Address
C.H. Regional Reina Sofia
Cordoba, Córdoba, 14004
Status
Recruiting
Address
Hospital Universitario A Coruña
a Coruña, , 15006
Status
Recruiting
Address
Hospital Universitario Vall d'Hebron
Barcelona, , 008035
Status
Recruiting
Address
Hospital de La Santa Creu i Sant Pau
Barcelona, , 8025
Status
Recruiting
Address
Hospital General Universitario Gregorio Marañon
Madrid, , 28007
Status
Recruiting
Address
Hospital Universitario La Paz - PPDS
Madrid, , 28046
Status
Recruiting
Address
Hospital Quironsalud Infanta Luisa
Sevilla, , 41010
Status
Recruiting
Address
Hospital Universitario Virgen del Rocio
Sevilla, , 41013
Status
Recruiting
Address
Hospital Universitario Doctor Peset
Valencia, , 46017
Status
Recruiting
Address
Inselspital Bern
Bern, Bern (de), 3010
Status
Recruiting
Address
HFR Fribourg Hôpital Cantonal
Fribourg, , 1708
Status
Recruiting
Address
Kantonsspital St. Gallen
Sankt Gallen, , 9000
Status
Recruiting
Address
The Royal Free Hospital
London, London, City Of, NW3 2QG